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Open Trial of an ACT Skills Group and Mobile App for Worry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03709433
Recruitment Status : Completed
First Posted : October 17, 2018
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Twohig, Ph.D., Utah State University

Tracking Information
First Submitted Date  ICMJE October 9, 2018
First Posted Date  ICMJE October 17, 2018
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE September 17, 2018
Actual Primary Completion Date March 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2018)
Penn State Worry Questionnaire (PSWQ) [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
The PSWQ is a 16-item self-report measure of problematic worry. The PSWQ has validity and reliability in clinical samples.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2018)
  • Penn State Worry Questionnaire (PSWQ) [ Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline) ]
    The PSWQ is a 16-item self-report measure of problematic worry. The PSWQ has validity and reliability in clinical samples.
  • State-Trait Anxiety Inventory (STAI) - Trait Subscale [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    The Trait subscale of the STAI is a 20-item self-report measure of trait anxiety. The STAI-T has demonstrated validity and reliability.
  • State-Trait Anxiety Inventory (STAI) - Trait Subscale [ Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline) ]
    The Trait subscale of the STAI is a 20-item self-report measure of trait anxiety. The STAI-T has demonstrated validity and reliability.
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    The BDI-II is a 21-item measure of depressive symptoms. It had good reliability and validity.
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline) ]
    The BDI-II is a 21-item measure of depressive symptoms. It had good reliability and validity in clinical samples.
  • Acceptance and Action Questionnaire (AAQ-II) [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    The AAQ-II is a 7-item measure of psychological inflexibility. It has demonstrated good reliability and validity.
  • Acceptance and Action Questionnaire (AAQ-II) [ Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline) ]
    The AAQ-II is a 7-item measure of psychological inflexibility. It has demonstrated good reliability and validity.
  • Believability of Anxious Thoughts and Feelings (BAFT) Questionnaire [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    The BAFT is a 16-item measure of fusion with anxious thoughts and feelings. It has demonstrated reliability and validity.
  • Believability of Anxious Thoughts and Feelings (BAFT) Questionnaire [ Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline) ]
    The BAFT is a 16-item measure of fusion with anxious thoughts and feelings. It has demonstrated reliability and validity.
  • Mindful Attention Awareness Scale (MAAS) [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    The MAAS is a 15-item measure of mindful awareness of one's experience. It has demonstrated reliability and validity. Each item is rated from 1 to 6, and a mean score is of all items is taken, therefore the overall score range is 1 to 6 with higher scores indicating higher mindfulness.
  • Mindful Attention Awareness Scale (MAAS) [ Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline) ]
    The MAAS is a 15-item measure of mindful awareness of one's experience. It has demonstrated reliability and validity. Each item is rated from 1 to 6, and a mean score is of all items is taken, therefore the overall score range is 1 to 6 with higher scores indicating higher mindfulness.
  • Valuing Questionnaire (VQ) - Progress subscale [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    The Progress subscale of the VQ is a 5-item measure of progress toward one's personal values. It has good validity and internal consistency.
  • Valuing Questionnaire (VQ) - Progress subscale [ Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline) ]
    The Progress subscale of the VQ is a 5-item measure of progress toward one's personal values. It has good validity and internal consistency.
  • PROMIS 8a Satisfaction with Social Roles and Activities [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    This scale is an 8-item measure of the degree to which one feels satisfied with their ability to participate in social roles and activities. This measure was developed through item response theory and has demonstrated good reliability and validity.
  • PROMIS 8a Satisfaction with Social Roles and Activities [ Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline) ]
    This scale is an 8-item measure of the degree to which one feels satisfied with their ability to participate in social roles and activities. This measure was developed through item response theory and has demonstrated good reliability and validity.
  • Mental Health Continuum-Short Form (MHC-SF) [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    The MHC-SF is a 14-item measure of psychological and social well-being. It has shown good reliability and validity.
  • Mental Health Continuum-Short Form (MHC-SF) [ Time Frame: One month after the posttreatment survey is administered (10-14 weeks after baseline) ]
    The MHC-SF is a 14-item measure of psychological and social well-being. It has shown good reliability and validity.
  • Credibility/Expectancy Questionnaire (CEQ) [ Time Frame: At the end of the first group therapy session, 0-4 weeks after baseline ]
    The CEQ is a 6-item measure of the credibility of a treatment approach and expectations of treatment outcomes. This measure has good reliability.
  • Mobile app question: "How much are you....Feeling nervous, anxious, or on edge" [ Time Frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline. ]
    This item was taken from the GAD-7, a well-validated measure of generalized anxiety. It will be used for an initial assessment each time participants begin to use the mobile app, and again after they practice one of the mobile app skills. It will be rated from 0-100.
  • Mobile app question: "How much are you....Worrying too much about different things" [ Time Frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline. ]
    This item was taken from the GAD-7, a well-validated measure of generalized anxiety. It will be used for an initial assessment each time participants begin to use the mobile app, and again after they practice one of the mobile app skills. It will be rated from 0-100.
  • Mobile app question: "How much are you....Feeling down, depressed, or hopeless" [ Time Frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline. ]
    This item was taken from the PHQ-9, a well-validated measure of depression. It will be used for an initial assessment each time participants begin to use the mobile app, and again after they practice one of the mobile app skills. It will be rated from 0-100.
  • Mobile app question: "How much are you....Fighting your feelings" [ Time Frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline. ]
    This item assesses momentary experiential avoidance. It is lacking full validation but has been used successfully in previous mobile app research.
  • Mobile app question: "How much are you....Stuck in thoughts" [ Time Frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline. ]
    This item assesses momentary cognitive fusion. It is lacking full validation but has been used successfully in previous mobile app research.
  • Mobile app question: "How much are you....Running on autopilot" [ Time Frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline. ]
    This item assesses momentary inattention. It is lacking full validation but has been used successfully in previous mobile app research.
  • Mobile app question: "How much are you....Disconnected from values" [ Time Frame: Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline. ]
    This item assesses momentary values obstruction. It is lacking full validation but has been used successfully in previous mobile app research.
  • Treatment Evaluation Inventory-Short Form (TEI-SF) [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    The TEI-SF is a 9-item measure of treatment acceptability. In this study two items were omitted and others were revised to be appropriate for the present sample. This measure has good reliability and has been demonstrated to discriminate between different treatments.
  • Novel satisfaction items [ Time Frame: At posttreatment (6-10 weeks after baseline) ]
    13 novel items were developed assessing satisfaction with the intervention (both overall and for specific components).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Trial of an ACT Skills Group and Mobile App for Worry
Official Title  ICMJE An ACT Skills Group and Mobile App for Worry
Brief Summary

This study is an open trial of acceptance and commitment therapy (ACT) groups combined with a mobile app for the treatment of Generalized Anxiety Disorder (GAD). The goal of this study is to evaluate if ACT groups and a mobile app are efficacious and acceptable in the treatment of GAD.

Study hypotheses are:

  1. Group ACT will lead to improvement in worry, anxiety, comorbid depression, functioning, and well-being.
  2. Group ACT will also lead to improvement in theoretically relevant processes, namely psychological inflexibility, anxiety-related fusion, mindfulness, and progress towards values.
  3. Combining a mobile app with group ACT will be credible, acceptable, and satisfactory to participants.
Detailed Description

Participants and power:

Each group will include 6-12 participants. The target sample size is 36 participants, which would provide good power (0.90) to detect a medium effect size in a repeated-measures ANOVA with three time points and requires running at least 3 groups.

All clinics on the Utah State University campus will be asked to refer their waitlist clients to the group, if appropriate (e.g., client presented with significant worry). Local private practitioners in the Cache Valley, Utah area may also be notified about the option to refer their waitlist clients to the group. Fliers will be posted on the Utah State University campus and in the local community and distributed to providers to provide more information on the study. Fliers will direct interested individuals to contact the researchers. The study will also be listed on the Utah State University Contextual Behavioral Science Lab website with a link to the pre-screening.

Procedures:

Individuals who contact the researchers expressing interest will be sent more information on study procedures and asked to complete a brief online pre-screening specific to this study.

If potential participants are likely to be eligible based on the online pre-screening, they will be asked to schedule an initial assessment. They will be asked to review a consent form and given an opportunity to ask any questions. Those who decide to participate and sign the consent form will be administered the MINI International Neuropsychiatric Interview to check eligibility (i.e., GAD diagnosis, no serious mental illness), then asked to complete a series of self-report measures hosted on Qualtrics on an iPad to establish a baseline.

The group intervention will begin when the groups are filled. There will be no cost or compensation for participating in the groups. They will be facilitated by two doctoral students with training in ACT. Participants will be informed about and trained in using the ACT Daily mobile app at the first group and reminded about how to use it at each weekly group. Reminders about using the app will also be sent weekly through email or text to participants in the follow-up period.

Participants will be asked to complete a credibility questionnaire on paper at the end of the first session. They will be asked to complete an online post-treatment survey after the group sessions conclude, and a final online follow-up survey one month later.

Intervention:

The group therapy intervention consists of six weekly sessions of acceptance and commitment therapy (ACT). Each session will be two hours long. The intervention was developed based on established ACT protocols and adapted to fit the group format and generalized anxiety. The intervention uses metaphors, experiential exercises, and discussion to target the core elements of ACT: acceptance, defusion, present moment awareness, self-as-context, values, and committed action. Groups will be closed (i.e. new group members will not be added as sessions progress). Sessions will be video recorded for the purposes of training and supervision and to allow for a review of treatment fidelity.

The ACT Daily mobile app is hosted on Qualtrics and teaches a variety of ACT skills targeting acceptance, defusion, present moment awareness, values, and committed action. Users will answer some brief questions regarding their current symptoms and psychological flexibility and then be recommended a tailored skill relevant to the psychological flexibility process that they report struggling with the most in the moment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
All participants will receive the same active treatment (acceptance and commitment therapy groups and a mobile app)
Masking: None (Open Label)
Masking Description:
No masking will be used.
Primary Purpose: Treatment
Condition  ICMJE Generalized Anxiety Disorder
Intervention  ICMJE Behavioral: ACT groups and mobile app
See arm description.
Study Arms  ICMJE Experimental: ACT groups and mobile app
Participants will receive six two-hour weekly sessions of acceptance and commitment therapy (ACT) in a group format. They will also access the ACT Daily mobile app, which helps participants practice ACT skills in the moment, for the duration of the study (10-14 weeks depending on when the participant completes the baseline assessment.) Sessions use metaphors, experiential exercises, and discussion to target core ACT skills: acceptance, defusion, present-moment awareness, self-as-context, values, and committed action. The mobile app includes metaphors and experiential exercises to aid with all of these skills except self-as-context. Participants will be asked to use the app to practice these skills and to complete behavioral commitments linked to their values between sessions.
Intervention: Behavioral: ACT groups and mobile app
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2020)
21
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2018)
36
Actual Study Completion Date  ICMJE April 15, 2020
Actual Primary Completion Date March 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Seeking treatment for worry
  2. Fluent in English
  3. At least 18 years old
  4. Have no serious mental illness
  5. Not currently receiving other treatment
  6. Meeting diagnostic criteria for generalized anxiety disorder

Exclusion criteria mirror inclusion criteria.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03709433
Other Study ID Numbers  ICMJE 9528
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael Twohig, Ph.D., Utah State University
Study Sponsor  ICMJE Utah State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Twohig, PhD Utah State University
PRS Account Utah State University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP